Note: Descriptions are shown in the official language in which they were submitted.
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(1) Field of the Invention
This invention relates to pressurizable, multi-
chambered, therapeutic devices, and more particularly to
methods of manufacturing sleeves for applying compressive
pressures against a patient's leg.
(2) Prior Art
Blood flow in patient's extremities, particularly
the legs, markedly decrease during extended terms of
confinement. Such pooling or stasis, is particularly acute in
surgery and during recovery periods immediately thereafter.
Blood flow compressive devices, such as shown in
U.S. Patents 4,013,069 and 4,030,488 develop and facilitate
the application of compressive pressures against a patient's
limbs and in so doing promoting venous return. The devices
comprise a pair of sleeves which are wrapped about the
patient's limbs, with a controller for supplying the
pressurized fluid to the sleeves.
These sleeve devices may be seen in U.S. Patents
4,402,312 and 4,320,746.
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One use for the above mentioned sleeves is the prevention
i of deep vein thrombosis (DVT) which sometimes occurs in
I! surgical patients who are confined to bed. When a DVT occurs,
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i th~~ valves that are located within the veins of the leg can be '
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~i damaged which in turn can cause stasis and high pressure in
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;i the veins of the lower leg. Patients who have this condition ;
!' often have leg swelling (edema) and tissue breakdown (venous
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'' stasis ulcer) in the lower leg.
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It has been shown that pneumatic compression can be
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li highly effective in the treatment of such edema and venous ;
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i ulcers. This treatment is usually performed by the patient
~~ themselves at home on a daily basis and requires that the i
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i' patient be able to put on and remove the sleeves unassisted. I
' The sleeve devices which are wrappable from a flat
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configuration as shown in the aforementioned patents, are
' difficult to apply by the patients themselves.
It is therefore an object of the present invention, to
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provide a compressible sleeve device which is easily ;
utilizable at home by the patient himself.
A further object of the present invention is to prepare a ,
'~i compressible sleeve device for optimizing therapy for venous
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,;; ulcers and edema associated with poor venous return.
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Brief Summary of the Invention
The present invention provides a method for the
manufacture of a limb compressible sleeve to permit a distal
to proximal sequential compression of a human limb, comprising
the steps of: fabricating an elongated outer sheet having a
first and a second end, with an intermediate portion extending
therebetween; fabricating an elongated inner film having a
first and a second end, with an intermediate portion extending
therebetween; juxtaposing said inner film onto said outer
sheet to align their peripheries; bonding generally transverse
seal lines across a first longitudinal half only of said
juxtaposed sheet and film to define a plurality of
compressible chambers therebetween; bonding generally
longitudinal seal lines across the other longitudinal half of
said juxtaposed sheet and film to define a compressible
chamber therebetween; folding said second half and said first
half together about a lateral fold line; and sealing said
first half and said second half along the peripheries thereof
that are common to define a sheath into which a patient may
insert a limb.
An elongated compressible sleeve device for
enclosing a length of a patient's limb has a plurality of sets
of adjoining laterally extending fluid pressure chambers. The
sleeve is comprised of a single elongated outermost sheet of
flexible fluid-impervious material such as urethane-coated
nylon.
An "inner" film of a suitable flexible material such
as urethane is disposed against the upper side of the "outer"
elongated sheet, having common sealed peripheral margins. The
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film is sealed with respect to the outer sheet to define a
plurality of pressurizable chambers. The outer sheet is most
preferably stiffer and inelastic relative to the inner film,
thereby permitting the inner layer to conform appreciably
better to the shape of the leg. Thus, the outer sheet will
remain relatively flat upon inflation while the inner film
inflates and the areas of the film defining adjacent chambers
press together, which in turn substantially inhibits zero
pressure areas. The elongated sheet and attached film is
folded upon itself along a transverse fold near its
longitudinal mid-point. The sheet is then joined along all of
one and a portion of its other longitudinal edges when folded
upon itself to leave one side open from the midpoint upwardly
for ease of inserting the limb, thereby forming a two-layered
sheath-like structure, open at its proximal end to define an
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inner film and outer sheet arrangement. A plurality of
conduits are arranged in fluid communication with their
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respective chambers, each conduit terminating in a connector !
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adjacent the open end cf the sleeve.
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The sleeve has a distal end which is closed by its
transverse fold, for the enclosed emplacement of a patient's
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foot. An oblong or generally oval non-inflatable pad is
I preferably enclosed between the inner and outer sheets at the
distal end of the sleeve, on top of the film, to provide a
I, cushion base for the patient's foot.
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The outer film of the topmost layer is positionable over
~, the front side of a patient's limb. An adhering or securement
~I' means is disposed along the front of the topmost layer.
The side edges of the topmost layer, from the proximal
end of the foot chamber, to the uppermost end of the sleeve,
I have an adhering strip attached therealong. The longitudinal .
side portions of the sleeve include margins or flap portions
which are foldable onto the adhering means, so as to
adjustably encase the wearer's limb in the sleeve.
The topmost layer comprises a pair of longitudinally
directed pressurizable chambers which are in fluid
communication with the pressurizable chamber above and
alongside the patient's foot.
A longitudinally directed centrally disposed sight line
may be arranged along the middle of the adhering means to
' permit the patient to line up the sleeve, so that the~sight
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line is aligned up the middle of the limb, permitting most
;i effective utilization of the compressive chambers on the limb.
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' When the sleeve fully encloses a patient's limb, and the
!~ marginal side flaps of the sleeve are wrapped over and stuck
to their respective sides of the adhering means, the
patient's limb is almost completely surrounded by inflatable
i' chambers, awaiting sequential pressurization. However, the
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front of a patient's leg is bony and hence requires no
pressurizable chambers. The important area is the muscular
area on the sides and back of a patient's leg, which contains
~~ the veins to which compressive pressure need be applied in
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accordance with this invention. The front side of the sleeve,
which comprises the tongue portion thereof, is inelastic, so
that when compression occurs in the remainder of the sleeve
and onto the leg, tension is applied across the curvature of
the tongue which in effect translates into pressure over the
radius of curvature along the front of a patient's leg.
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Brief Description of The Drawings
The objects and advantages will become more appar~.nt when j
~~ viewed in conjunction with the following drawings, in which:
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Figure 1 is a perspective view of a full limb length '
compressible sleeve constructed according to the principles of
the present invention; '
Figure 2 is another perspective view of the sleeve shown
~ in Figure 1, with a patient's limb depicted therein; j
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Figure 3 is a plan view of the elongated outer sheet,
which when folded generally along its transverse mid-point,
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comprises the outer layer of the sleeve;
Figure 4 is a plan view of an inner film disposed upon
the outer sheet having the chambers defined by seal margins
between the inner film and the outer sheet; and
' Figure 5 is a plan view of the sleeve, with the inner and
the outer sheet joined at their appropriate peripheral
locations.
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Description of The Preferred Embodiment
The present invention comprises a method of making an i
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'i elongated compressible sleeve 10 for enclosing a patient's
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,~ limb, such as a leg. The sleeve 10, shown in perspective view
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'~ in Figure 1, includes a plurality of adjoining generally i
~; transversely extending fluid pressurizable chambers 12, which
'I are shown more clearly in Figure 4.
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The sleeve 10 is comprised of an outermost flexible
ii fluid-impervious sheet 14, made of urethane-coated nylon, or j
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~~ the like, in an elongated form, as shown in Figure 3. The I
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~i outermost sheet 14 has a first end 16 and a second or opposed ,
ji end 18, each of which has a transverse dimension that narrows
!~ (tapers) slightly to a general mid-point of the sheet 14, i
defined by a transverse fold line 20.
The sleeve 10 is also comprised of an innermost flexible
fluid-impervious film 22, made of plastic material such as
urethane, having a peripheral outline, as shown in Figure 4,
which is generally similar to the configuration of the
outermost sheet 14. As previously stated, the outermost sheet
~' is stiffer and inelastic relative to the innermost film so
I that the latter conforms well to the shape of the leg while
I~ the former remains relatively flat upon inflation.
The film 22 has a first end 24 and a second end 26, each
I'' of which has a transverse dimension thst narrows slightly to a
general mid-point of the film 22 defined by the common
~~ transverse "fold" line 20. The peripheral outline of the
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innermost film 22 is substantially the same as the periphery ;
'~ of the uutPr~no>t sheet 14. Pt ef2ra.bly , however, the length of i
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the film 22, to the right of the common "fold" line 20 as !
;~ shown in Figure 4, is shorter than the corresponding length of
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~, the outer sheet 14, e.g. on the order of 20o shorter. ;,
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In both the outermost sheet 14, and the innermost film
22, the longer portion of each to one side of their common
fold line 20, comprises the backside portion 17 of the sleeve
having elongated side marginal portions 70 which wrap about
Ithe patient's limb from the backside thereat, which portions
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are to the left of the fold line 20, viewing Figure 2.
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The innermost film 22 is placed over the outermost sheet
14, with their common fold line 20 and their first ends 24 and ,
16 contiguous, as shown in Figure 4. The section of the
sleeve 10, to the right of the fold line 20, as shown in
Figure 4; comprises the frontside portion 19, of the sleeve
10, when the film 22 and sheet 14 are folded along the fold
line 20, onto themselves, to form the sleeve.
The innermost film 22 may then be sealed to the outermost
sheet 14 generally at the periphery 23 of film 22 and at seal
lines 32 which also define a plurality of longitudinally
directed constant pressure chambers 12 between the innermost
~ film 22 and the outermost sheet 14, the seal lines 32 and
chambers 12 being shown in Figure 4 prior to the folding of '
the elongated sheet 14 and film 22 and subsequent peripheral
joining. Suitable sealing means, e.g. radio frequency (RF) I
sealing means, will be readily suggested to those skilled in
the art.
A foot pad 36, of generally oval shape, is
nUn-pr.=asurizably disposed bezweea The sheet 14 and the film
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22, to form a cushion against which a patient's foot is
placed, as may be seen in Figure 2. A front pressurizable
chamber 34, partially bifurcated, is disposed to the right of
the fold line 20 of Figure 4, the front chamber 34 being in
fluid communication with a chamber 35 which extends around the
side portions of the foot pad 36. The bifurcated chamber 34
eliminates any pressure chamber juxtaposed against the very
forwardmost bony part of a patient's leg, when it is enclosed
in the sleeve 10. This in turn applies compression to the
flat leg sections on either side of the forwardmost bony
portion of the lower leg. Since these flat leg sections are
the sites of many ulcers, it follows that they are important
areas for applying compressive pressure in accordance with
this invention. The backside portion 17 of the sleeve 10
includes a lowermost pressurizable ankle chamber 38, an
intermediate calf chamber 40, a first thigh chamber 42 and an
upper thigh chamber 44. Each chamber 38, 40, 42 and 44 has an
orifice 46 for the sequential pressurization and de-
pressurization of those chambers, through a plurality of
conduits 50, through a coupling adapter 51, which is in fluid
communication through further conduits 53 with a compression
generator, as identified in various patents including those
referred to above. The chamber 35, disposed about the sides
and forepart of the pad 36, as well as the pressurizable
chamber 34 in the frontside of the sleeve 10, including the
top of the foot, is maintained at a constant base pressure of
about 10 pounds pressure, from a pressure generating source as
aforementioned.
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During assembly of the sleeve 10, the frontside 19
of the sleeve 10 is folded over onto the backside portion 17
of the sleeve 10, along their common fold line 20, and are
joined, as
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' by stitching or the like, along only their common peripheral !
~~ points, as indicated by "P", shown in Figure 5. The common
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I' peripheral points P may be recited as one generally
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I; longitudinally common side edge 52, and another side edge 54, I
~~' only a portion of which is common to the frontside 19 and the
backside 17. A longitudinal opening 56 extends almost
half-way along one longitudinal side, and the sleeve 10 is
~ open at its proximalmost end 60, to permit, in conjunction '
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with the side opening 56, a patient to easily slide his leg
!~ "L" into the sheath-like arrangement of the sleeve 10.
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A generally rectangular (slightly truncated) patch of
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'~ receiving cloth 62 is secured to the outside upper portion of '
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the frontside 19, of the sleeve, as shown in Figures 1, 2, 3, I
and 5. A narrow strip 64 of hook means, such as the
trademarked "Velcro" material, is attached adjacent the
elongated marginal side edges 70, as shown in Figures 1, 2,
and 5.
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After a patient has placed his leg or limb in the
sheath-like sleeve 10, the longitudinal side portions along
the proximal segment of the sleeve 10, may be wrapped about
' the patient's limb "L" as shown in Figure 2, so that the
narrow strip 64 of hook means engages the receiving cloth 62
to encircle the patient's limb. A marker line "M" as shown in
Figure 1, may be disposed on the topside of the receiving
cloth 62, to facilitate alignment of the sleeve with the front
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mid-portion of the patient's limb (leg).
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!! Air or other pressurizable fluid may than be directed
through the conduits into the chambers 39, 38, 40, 42 and 44
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;; in the sequence and pressure profile created by the pressure
generator aforementioned.
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In view of the foregoing description and illustrative
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drawings, it will thus be appreciated that the present
invention provides a therapeutic device for applying
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compressive pressure against the leg, which device is easily
applied and removed by the patient and is accordingly
~ particularly suitable for home care.
Apart from this advantage, the construction and
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I~ arrangement of elements of the therapeutic device of this j
~~ invention provides further significant advantages which can
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n best be described by reference to the physiology of the
patient's leg.
As was previously stated, the important area to be
subjected to compression is the muscular area on the sides and
particularly on the back of the leg. The front of the leg is
bony and hence does not require this treatment. Accordingly,
the front side of the sleeve, which comprises the tongue
portion thereof, is not provided with sequential compression
chambers. Moreover, the tongue portion is inelastic so that
compression occurring at the back of the leg causes tension to
be applied to the inelastic tongue portion which is in turn
I translated to pressure over the radius of curvature at the
I front of the leg.
It will also be seen from the foregoing description that
there is no compression applied to the bottom of the foot.
Since bloor7 does not pool there, edema does not occur and
c~~nseguent Ly l:l:ore is no neea to apply comj~ressi~n. On the
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~' other hand, if the bottom of the foot portion were inflated to
apply compression, the resulting pressure patterns would be
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~~ changed if the patient stood on his feet, which the patient is
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indeed permitted to do when wearing the therapeutic device of
' this invention.
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Yet another important advantage is obtained from the use
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~ of an outer sheet which is relatively stiff and inelastic and
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~~ an inner film which is soft and compliant. Apart from the
~; fact that it is desirable to have an abrasion resistant outer i
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surface, this combination of outer sheet and inner film i
I! permits the inner film to conform substantially to the shape
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Ij of the individual leg. Accordingly, zero pressure points are i
~' substantially precluded, thus obviating the so-called
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corrugation effect typically seen when prior hospital
~! compressible sleeve devices are used on edematous legs.
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